dideco VANGUARD D921 Instrucciones Para El Uso página 3

INSTRUCTIONS FOR USE
I. CONTENTS
I. Contents
A. Description
B. Technical specifications
C. Intended use
D. Safety information
E. Assembly
F. Priming procedure
G. Administration procedure
H. Replacing the cardioplegia set
I. Medical devices for use with cardioplegia sets
J. Limited warranty
A.DESCRIPTION
D921, D924, D924S, D928S, D924P are circuits designed to
administer cardioplegic solution containing blood with a fixed
blood/asanguineous cardioplegic solution ratio.
Cardioplegic solution is used for perfusion of the coronaries
during cardiopulmonary by-pass, when the aorta is clamped
and the intention is to protect the myocardium during the
anoxic phase. The sets are disposable, non-toxic and non-pyro-
genic and are supplied STERILE in individual packs. They are
sterilized with ethylene oxide.
The residual ethylene oxide level in the sets complies with the
requirements of the legislation in force in the country of use.
The sets comprise:
1. Two delivery lines for the asanguineous cardioplegia solution
and oxygenated blood which also act as pump segments.
The asanguineous solution line is bifurcated to allow the use
of two different cardioplegic solutions (if only one type of car-
dioplegic solution is used, the unused line must be clamped).
2. VANGUARD heat exchanger with integrated bubble trap,
pressure line (with transducer protection) and temperature
probe port.
3. Delivery line.
4. 1 Three-way stopcocks (for pressure and vent lines).
5. Shunt between the blood line and the asanguineous cardio-
plegic solution line for administration of blood only and a luer
connector on the blood line to allow the provision of different
ratios using an infusion pump (model D924S, D928S).
B.TECHNICAL SPECIFICATIONS
The sets differ in the ratios of blood to cardioplegic solution and
whether or not they are equipped with shunt and luer.
More specifically:
- D924 (4 parts blood and 1 part asanguineous cardioplegic
solution).
- D924S ( 4 parts blood and 1 part asanguineous cardioplegic
solution); with shunt between the blood line and the asangui-
neous cardioplegic solution line for administration of blood
only and a luer connector on the blood line.
- D921 ( 1 part blood and 1 part asanguineous cardioplegic
solution).
- D928S (8 parts blood and 1 part asanguineous cardioplegic
solution); with shunt between the blood line and the asan-
guineous cardioplegic solution line for administration of blood
only and a luer connector on the blood line.
- D924P ( 4 part blood and 1 part asanguineous cardioplegic
solution).
- VANGUARD heat exchanger:
- Hansen connectors for connections to the thermocirculator
- temperature monitoring port
- cardioplegic solution inlet connector 1/4" (6.4 mm)
- cardioplegic solution outlet connector 3/16" (4.8 mm)
- luer connector for vent line
- pressure monitoring line
- bubble trap with 105 micron filter
- priming valve
C.INTENDED USE
D921, D924, D924S, D928S, D924P are sets for the admini-
stration of cardioplegic solution containing blood, with the aid
of a low flow pump.
This set allows control of the flow, the temperature and infusion
(line) pressure of the cardioplegic fluid. The pump permits total
control of the infusion parameters, flow and quantity of solution
delivered. The perfusion temperature depends on the thermal
parameters of the cold water source which supplies the VAN-
GUARD heat exchanger.
Sets must not be used for more than 6 hours. Contact with the
perfusion solution for longer periods is not recommended.
Sets must be used in combination with the medical devices
listed in point I (Medical devices for use with cardioplegia sets).
D.SAFETY INFORMATION
In the text, information intended to draw the user's attention to
the need to prevent hazardous situations and assure correct,
safe use of the device are identified as follows:
CAUTION
Indicates serious consequences and potential dangers for the
user and/or the patient deriving from the use of the device in
normal conditions of use or improper use, as well as limita-
tions on its use and the measures to be taken if these events
should occur.
PRECAUTION
Indicates every possible precaution the user must take for
safe, effective use of the device.
KEY TO THE SYMBOLS USED ON THE LABELS
For single use only (Do not reuse)
Manufacturing batch
Batch code (number)
LOT
(reference for product traceability)
Use by (Expiry date)
Sterile - Ethylene oxide sterilised
STERILE
Non sterile
NON STERILE
REF
Catalogue (code) number
Attention, see instruction for use
This way up
Fragile; handle with care
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